Notice: Prescription Drug List (PDL): Naproxen

September 25, 2014
Our file number: 14-111561-673

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for naproxen on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of naproxen against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which remains unchanged from what was proposed in the June 4, 2014 Notice of Consultation, is:

Drugs containing any of the following: Naproxen or its salts

Including (but not limited to):

Qualifier: except when sold for oral use with a daily dose equivalent to 400 milligrams of naproxen base

Effective Date: 6 months from date of this Notice

Consultation summary:

The proposal to amend the PDL was communicated to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations through a Notice of Consultation posted on Health Canada's website on June 4, 2014. The 75 day consultation period which ended August 18, 2014 has been completed.

No comments were received on this consultation. Based on the results of this consultation, the Minister of Health intends to revise the listing for naproxen by permitting flexibility in using different salts, either individually or in combination with the naproxen base. There are no safety or effectiveness concerns in allowing this flexibility. This revision will be in effect six months from the date of this Notice through a Notice of Amendment posted on the Health Canada website.

Should you have any questions on this update to the Prescription Drug List, please contact:

Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9
Email: drug_prescription_status-statut_d'
Phone: 613-957-1058
Fax: 613-941-5035

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